A Study of SER-155 to Treat Diarrhea in People on Immunotherapy

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Jan 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SER-155 to help people experiencing diarrhea caused by their cancer immunotherapy. The researchers want to see if SER-155 is safe to use and if it causes few or mild side effects. They are looking for participants who are at least 18 years old, have received immunotherapy within the last 180 days, and are dealing with moderate diarrhea that their doctor believes is likely related to that treatment. Participants should also be able to take oral medication and agree to use birth control if they are able to have children.

If you join this study, you will receive SER-155 and be monitored for any effects, both good and bad. There are some health conditions that could prevent you from participating, such as certain infections, severe symptoms, or previous digestive diseases. The trial is currently recruiting participants of all genders, and you will need to provide consent and follow study guidelines throughout the process. This trial could be an important step in finding better ways to manage diarrhea for patients undergoing immunotherapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \> 18 years
• • Receipt of ICI (single-agent or combination) within the 180 days preceding screening.
• • Concurrent treatment with cytotoxic chemotherapy or other tumor-directed agents is permitted.
• • Grade 2 - 3 diarrhea (i.e., increase of at least 4 bowel movements a day above baseline during the screening window), deemed by the treating provider as likely related to ICI therapy, with or without concomitant symptoms of grade 1 - 2 colitis (e.g.
• • abdominal pain, bloody or mucoid stools)
• • Able to swallow oral medication
• • Individuals of childbearing potential willing to use a highly effective method of contraception (failure rate of \<1% per year when used consistently and correctly) for 30 days after the last dose of SER-155.
• • Willing to provide written informed consent, comply with the protocol, and understand the potential risks and benefits of study enrollment and treatment.
• Exclusion Criteria:
• • Active GI infection, including untreated viral, bacterial or fungal cause(s) of diarrhea.
• • Received immunosuppressive therapies for suspected or confirmed irEC, including systemic corticosteroids (either oral or intravenous) and/or infliximab, vedolizumab or ustekinumab
• • Grade 3 colitis symptoms, i.e. severe abdominal pain or peritoneal signs
• • Admitted to the hospital for irEC
• • Prednisone (or steroid equivalent) dose \> 10 mg a day for a non-GI irAE at time of screening
• • Pre-existing inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or microscopic colitis
• • Pregnant or lactating women
• • Any condition that requires ongoing prophylactic or therapeutic antibacterial antibiotics
• • Severe neutropenia, as defined by an absolute neutrophil count (ANC) \< 500 cells/mm\^3, at time of screening
• • Treatment with investigational medications used for diarrhea/colitis treatment and microbiome therapeutics within 30 days prior to enrollment
• • Known allergy or intolerance to oral vancomycin
• • Unable to comply with the protocol requirements
• • Any condition that in the opinion of the investigator may increase the risk of study participation and/or may interfere with the interpretation of study results